GMP Project Manager
Apply NowCompany: Merck Group
Location: Saint Louis, MO 63129
Description:
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
The GMP Project Manager position will develop and implement engineering solutions to problems and opportunities at the Cherokee Facility in St. Louis, MO. You will manage multiple projects concurrently, participate in cross functional teams, and training to maintain and expand technical expertise. The GMP Project Manager will coordinate schedules with stakeholders and manufacturing, manage the day-to-day project activity, and manage the knowledge transfer from end to end focusing on Project Integration from concept through validation. Included, but not limited to, is responsibility for the scope development, funding approvals, concept and detailed engineering, contractor selection, execution, commissioning, and turnover package to site support teams including AutoCAD drawings, PM plans, spare parts, asset records, and knowledge transfer. This position is based in St. Louis at 3300 South Second.
Responsibilities:
Who You Are:
Minimum Qualifications:
Preferred Qualifications:
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
The GMP Project Manager position will develop and implement engineering solutions to problems and opportunities at the Cherokee Facility in St. Louis, MO. You will manage multiple projects concurrently, participate in cross functional teams, and training to maintain and expand technical expertise. The GMP Project Manager will coordinate schedules with stakeholders and manufacturing, manage the day-to-day project activity, and manage the knowledge transfer from end to end focusing on Project Integration from concept through validation. Included, but not limited to, is responsibility for the scope development, funding approvals, concept and detailed engineering, contractor selection, execution, commissioning, and turnover package to site support teams including AutoCAD drawings, PM plans, spare parts, asset records, and knowledge transfer. This position is based in St. Louis at 3300 South Second.
Responsibilities:
- Develop project requirements, deliverables, schedules, and budget
- Manage capital project scope, budget, and schedule through project life cycle
- Procure necessary contractors, materials, and equipment to support projects. Work with General Contractors, skilled construction workers, internal skilled resources, and Engineers
- Coordinate schedules with stakeholders and manufacturing, manage the day-to-day project activity, and manage the knowledge transfer from end of project to manufacturing startup
- Responsibility for the turnover package to site support teams including AutoCAD drawings, PM plans, spare parts, asset records, and knowledge transfer
- Manage all aspects of engineering projects
- Supports the Management of Change process and utilizes good documentation practices
- Ensures GMP compliance (e.g. work order processing, good documentation practices, compliance to change management process, deviation review, CAPA assignments, etc.)
- Responsible for installation and maintainability of GMP utilities, facilities, and equipment such as but not limited to HVAC, compressed gases, process water, clean steam, chilled water, cleanrooms, glovebox isolators, HEPA filtration, etc
- Monitors the performance and results of the construction team including safety, quality, reliability, and availability of assets metrics
- Performs effective problem solving and root cause analysis to resolve issues, develop options, and prevent reoccurrence
Who You Are:
Minimum Qualifications:
- Bachelor's Degree in an Engineering discipline (Chemical, Mechanical, etc)
- 3+ years engineering experience within a pharmaceutical, chemical, or production experience
- 2+ years managing capital engineering projects
Preferred Qualifications:
- Hands on experience and strong project management skills in an industrial environment
- Strong technical engineering skills
- GMP manufacturing, engineering, or compliance experience
- Demonstrated ability to work within a cross-functional team
- Excellent interpersonal and team building skills
- Skilled on Microsoft Suite of Applications (Outlook, Word, Excel, Project, Power Point), and other project management tools
- 5+ years engineering experience within a pharmaceutical or chemical production environment
- Engineering experience in a cGMP environment
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html